Comparator clinical trial of CP-010 with Magnesium Phosphoricum in sub-chronic & chronic painful conditions.
- Conditions
- Health Condition 1: R52- Pain, unspecifiedHealth Condition 2: null- sub-acute and chronic pain
- Registration Number
- CTRI/2012/02/002450
- Lead Sponsor
- Homeopathy India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
Patients with moderate to severe pain at baseline (NRS 4 - 10) (Indicating the intensity of pain.),Any Sub-acute and chronic painful condition.Patients who continue to have significant pain in spite of any form of pain killer medication. Such patients should be able to manage without increasing the dose of current pain-killers or changing to another pain-killer medicine, during the course of study. Patient has been informed about the study and has given her/his written informed consent.Patient understands the investigational nature of the extension study and is willing and willing to comply with trial protocol. Patients having any sub-acute or chronic pain.
Patients with severe pain due to critical conditions such as chronic abdominal conditions such as appendicitis, cholicytisis, pancreatitis, renal colic, acute rheumatoid arthritis, severe psoriatic arthritis, septic arthritis, etc.Pregnant and lactating women,Mentally retarded patients,Patients with severe or incapacitating baseline pain.Participation in a clinical trial with an investigational agent during the past 30 days or Simultaneous participation in a clinical study, Severe uncontrolled systemic disease such as diabetes, hypertension.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical trial to evaluate the efficacy of potentized preparation CP-010 30c potency by measuring the reduction in intensity of pain using Numeric rating scale (NRS)Timepoint: Efficacy end points weekly at week 1 and week 2.
- Secondary Outcome Measures
Name Time Method Global Impression(CGI)scale10. <br/ ><br>Effect of pain on sleep. <br/ ><br>Number of patients report adverse reactions <br/ ><br>Need for Rescue Medication <br/ ><br>Change in Vital signs <br/ ><br>Laboratory evaluations <br/ ><br>Changes in symptoms. <br/ ><br>Time needed for the patient to be symptom free. <br/ ><br>Duration of period of relief <br/ ><br>Timepoint: Clinical- at 1 week and week 2, lab parameters after 2 weeks.